Experiences With Counterfeit Aesthetic Medical Devices and Injectables: A National Survey.

Szczegóły
Abstrakt

Tytuł:: Experiences With Counterfeit Aesthetic Medical Devices and Injectables: A National Survey.
Autorzy:: Wang JV; Department of Dermatology and Cutaneous Biology, Thomas Jefferson University, Philadelphia, Pennsylvania.
Hattier G; Department of Dermatology and Cutaneous Biology, Thomas Jefferson University, Philadelphia, Pennsylvania.
Rohrer T; SkinCare Physicians, Chestnut Hill, Massachusetts.
Zachary CB; Department of Dermatology, University of California, Irvine, California.
Saedi N; Department of Dermatology and Cutaneous Biology, Thomas Jefferson University, Philadelphia, Pennsylvania.
Źródło:: Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] [Dermatol Surg] 2020 Oct; Vol. 46 (10), pp. 1323-1326.
Typ publikacji:: Journal Article
Język:: English
Imprint Name(s):: Publication: 2021- : [Philadelphia] : Wolters Kluwer Health
Original Publication: New York, NY : Elsevier Science, c1995-
MeSH Terms:: Quality Control*
Cosmetic Techniques/*statistics & numerical data
Counterfeit Drugs/*adverse effects
Fraud/*statistics & numerical data
Practice Patterns, Physicians'/*statistics & numerical data
Cosmetic Techniques/adverse effects ; Cosmetic Techniques/instrumentation ; Cosmetic Techniques/standards ; Fraud/prevention & control ; Humans ; Injections/adverse effects ; Injections/standards ; Injections/statistics & numerical data ; Patient Safety/standards ; Patient Safety/statistics & numerical data ; Practice Patterns, Physicians'/standards ; Reproducibility of Results ; Societies, Medical/statistics & numerical data ; Surveys and Questionnaires/statistics & numerical data ; United States ; United States Food and Drug Administration/standards
References:: Wang JV, Zachary CB, Saedi N. Counterfeit esthetic devices and patient safety in dermatology. J Cosmet Dermatol 2018;17:396–7.
Biesman BS, Patel N. Physician alert: beware of counterfeit medical devices. Lasers Surg Med 2014;46:528–30.
Stevens WG, Spring MA, Macias LH. Counterfeit medical devices: the money you save up front will cost you big in the end. Aesthet Surg J 2014;34:786–8.
Bradshaw S. Cosmetic practitioners take huge risks purchasing and administering illegal botulinum toxin drug products. J Drugs Dermatol 2017;16:936–8.
Beer K, Rothschild K. Importing injectables. J Drugs Dermatol 2014;13:1156–8.
Pickett A. Serious issues relating to counterfeit dermal fillers available from internet sources. J Am Acad Dermatol 2011;65:642–3.
Pickett A, Mewies M. Serious issues relating to the clinical use of unlicensed botulinum toxin products. J Am Acad Dermatol 2009;61:149–50.
U.S. Food and Drug Administration. FDA Issues Letters to Doctors Who May Have Purchased Counterfeit or Unapproved Prescription Drugs. Available from: https://www.fda.gov/drugs/drug-supply-chain-integrity/fda-issues-letters-doctors-who-may-have-purchased-counterfeit-or-unapproved-prescription-drugs. Accessed September 9, 2019.
Substance Nomenclature:: 0 (Counterfeit Drugs)
Entry Date(s):: Date Created: 20200103 Date Completed: 20210106 Latest Revision: 20210206
Update Code:: 20240104
DOI:: 10.1097/DSS.0000000000002307
PMID:: 31895259
: Czasopismo naukowe

Background: Counterfeit medical devices and injectables have recently garnered interest in the field of aesthetics. Unlike their original counterparts, these counterfeit products have neither been tested nor verified using certified quality control measures.
Objective: Our study investigated the pervasiveness of counterfeit products in the field as well as the experiences and attitudes of practitioners.
Materials and Methods: An online survey was distributed to current members of the American Society for Dermatologic Surgery (ASDS) and the American Society for Laser Medicine and Surgery (ASLMS).
Results: For medical devices, 37.4% have encountered counterfeits and 20.1% have experienced patients with adverse events from them. For injectables, 41.1% have encountered counterfeits and 39.7% have experienced patients with adverse events from them. Compared with their original, most respondents believe that counterfeits are worse in terms of reliability, safety, and effectiveness. The majority also believe that counterfeits are either very or extremely endangering to patient safety.
Conclusion: Counterfeit medical devices and injectables are not uncommonly encountered. Overall, practitioners believe counterfeits are endangering patient safety and result in adverse events and think that either stricter rules and regulations or better enforcement of existing regulations is necessary.

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